glofitamab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antitumor, monoclonal antibodies 5736 2229047-91-8

Description:

MoleculeDescription

Molfile

Synonyms:

  • glofitamab
  • glofitamab-gxbm
  • columvi
  • RG6026
Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells. By simultaneous binding to CD20 on the B cell and CD3 on the T cell, glofitamab mediates the formation of an immunological synapse with subsequent T-cell activation and proliferation, secretion of cytokines and release of cytolytic proteins that results in the lysis of CD20-expressing B cells.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
June 15, 2023 FDA GENENTECH INC
July 7, 2023 EMA ROCHE REGISTRATION GMBH

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 923.35 51.19 176 1020 27797 90599454
Disease progression 125.41 51.19 54 1142 156561 90470690
Neutropenia 100.88 51.19 52 1144 224852 90402399
Febrile neutropenia 83.77 51.19 41 1155 158308 90468943
Death 75.94 51.19 56 1140 456495 90170756
Immune effector cell-associated neurotoxicity syndrome 69.75 51.19 16 1180 5752 90621499
Tumour flare 68.73 51.19 11 1185 585 90626666
Diffuse large B-cell lymphoma recurrent 66.02 51.19 14 1182 3512 90623739

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 1298.68 55.61 311 1538 44216 42575270
Disease progression 300.52 55.61 138 1711 143518 42475968
Immune effector cell-associated neurotoxicity syndrome 191.21 55.61 50 1799 9411 42610075
Off label use 89.09 55.61 122 1727 638213 41981273
Neutropenia 65.57 55.61 60 1789 199371 42420115
Tumour flare 64.98 55.61 14 1835 1139 42618347
Infection 58.20 55.61 44 1805 112024 42507462

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytokine release syndrome 2091.66 56.40 454 2407 69852 110516586
Disease progression 371.02 56.40 161 2700 243873 110342565
Immune effector cell-associated neurotoxicity syndrome 209.24 56.40 53 2808 14729 110571709
Neutropenia 144.53 56.40 100 2761 374520 110211918
Off label use 129.17 56.40 174 2687 1500011 109086427
Death 99.13 56.40 105 2756 698764 109887674
Febrile neutropenia 95.58 56.40 73 2788 316694 110269744
Tumour flare 85.75 56.40 17 2844 1550 110584888
COVID-19 81.70 56.40 60 2801 245000 110341438
Diffuse large B-cell lymphoma recurrent 81.27 56.40 21 2840 6278 110580160

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX28 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA PE N0000009267 Increased Cytokine Activity
FDA MoA N0000175078 CD20-directed Antibody Interactions
FDA MoA N0000175617 CD3-directed Antibody Interactions
FDA MoA N0000175618 CD3 Receptor Agonists
FDA MoA N0000182136 Cytochrome P450 Inhibitors
FDA EPC N0000194063 Bispecific CD20-directed CD3 T Cell Engager
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
amivantamabbelantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabgemtuzumab ozogamicinipilimumab show all 29 →

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Relapsed or refractory diffuse large B-cell lymphoma indication 1172695008




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
B-lymphocyte antigen CD20 Surface antigen ANTIBODY BINDING EC50 8.37 DRUG LABEL DRUG LABEL
T-cell surface glycoprotein CD3 epsilon chain Surface antigen ANTIBODY BINDING Kd 8.35 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEBI:757511 CHEBI
CHEMBL4298092 ChEMBL_ID
C000720108 MESH_SUPPLEMENTAL_RECORD_UI
12758 IUPHAR_LIGAND_ID
DB16371 DRUGBANK_ID
1363208001 SNOMEDCT_US
4042335 VANDF
4042336 VANDF
C5418242 UMLSCUI
11145 INN_ID
368342 MMSL
41694 MMSL
d10070 MMSL
019472 NDDF
D11833 KEGG_DRUG
06P3KLK2J8 UNII
2639781 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Columvi HUMAN PRESCRIPTION DRUG LABEL 1 50242-125 SOLUTION, CONCENTRATE 2.50 mg INTRAVENOUS BLA 31 sections
Columvi HUMAN PRESCRIPTION DRUG LABEL 1 50242-125 SOLUTION, CONCENTRATE 2.50 mg INTRAVENOUS BLA 31 sections
Columvi HUMAN PRESCRIPTION DRUG LABEL 1 50242-127 CONCENTRATE 10 mg INTRAVENOUS BLA 31 sections
Columvi HUMAN PRESCRIPTION DRUG LABEL 1 50242-127 CONCENTRATE 10 mg INTRAVENOUS BLA 31 sections